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Elastography in Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT01102127
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
Castilla-León Health Service

Brief Summary:
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

Condition or disease Intervention/treatment
Nodular Goiter Thyroid Cancer Device: Elastography

Detailed Description:

Aims:

Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.

Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.

Patient selection:

Inclusion criteria:

  • Age > 18 yr.
  • Recruitment in Endocrinology Clinics.
  • Nodular goiter.
  • Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria:

  • Toxic nodules
  • Non-accessible nodules to US or FNA
  • Cystic nodules
  • Nodules with calcifications in egg rind
  • Contraindication for FNA

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
Study Start Date : February 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Goiter
Patients with nodular goiter
Device: Elastography
Performance of US, elastography and FNA.




Primary Outcome Measures :
  1. Diagnostic accuracy of elastography for thyroid cancer [ Time Frame: 1 day ]
    Sensitivity, specifity, predictive values


Biospecimen Retention:   Samples Without DNA
Thyroid cells


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population with nodular goiter.
Criteria

Inclusion Criteria:

  • Age > 18 yr.
  • Recruitment in Endocrinology surgery.
  • Nodular goiter.
  • Multinodular goiter with dominant nodule > 1 cm.

Exclusion Criteria:

  • Toxic nodules
  • Non-accessible nodules to US or FNA
  • Cystic nodules
  • Nodules with calcifications in egg rind
  • Contraindication of FNA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102127


Locations
Spain
Complejo Asistencial de León
León, Spain, 24008
Sponsors and Collaborators
Castilla-León Health Service
Investigators
Principal Investigator: Alfonso Vidal-Casariego, MD Complejo Asistencial de León

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfonso Vidal-Casariego, Complejo Asistencial de León
ClinicalTrials.gov Identifier: NCT01102127     History of Changes
Other Study ID Numbers: TNUS122009
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: April 2011

Keywords provided by Castilla-León Health Service:
elastography
thyroid nodule
fine-needle aspiration

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Goiter, Nodular
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Goiter